Intraocular Pressure Data Collection With Tonometers

Intraocular Pressure Clinical Trial

Official title:

Intraocular Pressure Data Collection With Tonometers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450587
• Other study ID #: TA032-082
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Icare Finland Oy
• Contact: Matjaž Mihelcic, Dr.
• Phone: +386 41 796 133
• Email: matjaz.mihelcic[@]siol.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).

The intraocular pressure of the participants will be measured with four different tonometers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

Exclusion Criteria:

• Subjects with only one functional eye

• Subjects having poor or eccentric fixation in the study eye(s)

• High corneal astigmatism >3D in the study eye(s)

• Central corneal scarring

• History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)

• Microphthalmos

• Buphthalmos

• Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally

• Dry eyes (clinically significant)

• Lid squeezers - blepharospasm

• Nystagmus

• Keratoconus

• Any other corneal or conjunctival pathology or infection relevant to this study

• Cataract Extraction within last 2 months in the study eye(s)

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• iCare IC1000
Measurement of Intraocular Pressure (IOP)
• iCare ST500
Measurement of Intraocular Pressure (IOP)
• iCare IC200
Measurement of Intraocular Pressure (IOP)
• GAT
Measurement of Intraocular Pressure (IOP)

Locations

Country	Name	City	State
Slovenia	Optika Mesec d.o.o.	Bled
Slovenia	Vid d.o.o.	Kromberk	Nova Gorica

Sponsors (1)

Lead Sponsor	Collaborator
Icare Finland Oy

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.	Through study completion, an average of 4 months